Fluid reservoirs for penile implant devices and methods of manufacturing

ABSTRACT

A fluid reservoir for a penile implant device that includes a body portion having a sleeve from which a tube may extend. The body portion includes support structure positioned at an interior surface of the body portion near an orifice of the reservoir, which orifice leads to a fluid passage of the tube. The support structure may comprise a plurality of protrusions that are arranged around the orifice and that extend from a base portion of the body portion. The invention also relates to a method of manufacturing a fluid reservoir for a penile implant device, which includes positioning a tube in a mold and injection molding a reservoir body onto the tube. More particularly, the method may include providing a mold, positioning a tube in the mold, injecting material into the mold, curing the material, and opening the mold to remove the reservoir body and tube assembly.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional applicationshaving Ser. No. 60/507,972, filed Oct. 2, 2003, entitled “FLUIDRESERVOIRS FOR PENILE IMPLANT DEVICES AND METHODS OF MANUFACTURING”, andSer. No. 60/507,974, filed Oct. 2, 2003, entitled “PENILE IMPLANTRESERVOIRS AND METHODS OF MANUFACTURING”, which applications areincorporated herein by reference in their entireties.

TECHNICAL FIELD

The present invention relates generally to surgical implant devices andmethods of making such devices. More particularly, the present inventionrelates to fluid reservoirs for use with penile implant devices andmethods of making such reservoirs.

BACKGROUND OF THE INVENTION

One common treatment for erectile dysfunction includes the use of apenile implant device. One type of penile implant device, commonly knownas a three-piece device, includes a pair of inflatable cylindricalprostheses that are implanted into the corpus cavernosae of the penis,which are connected to a fluid-filled reservoir through a pump and valveassembly. Such a pump and valve assembly is typically implanted into thescrotum of the patient, and the reservoir is implanted in the abdomen.Tubing is used to connect each penile prosthesis to the pump, andadditional tubing is used to connect the pump to the reservoir. Toactivate the penile implant device, the patient would typically actuatethe pump using one of a variety of methods that cause fluid to betransferred from the reservoir through the pump and into the prostheses.This results in the inflation of the prostheses and produces rigidityfor a normal erection. Then, when the patient desires to deflate theprostheses, a valve assembly within the pump is actuated in a mannersuch that the fluid in the prostheses is released back into thereservoir. This deflation returns the penis to a flaccid state.

The reservoir used in these three-piece systems is usually in the formof a flexible bag or bladder that can expand and contract in volume withmovement of fluid to and from the reservoir. One commonly used methodfor manufacturing these reservoirs is by a dip coating process. Dipcoating consists of introducing a mandrel of a desired geometry into aself-leveling thermoplastic or thermosetting material (e.g., a siliconedispersion of a specific solids content and viscosity). Much likeold-fashioned candle making, the mandrel is repeatedly dipped into thedispersion until a desired wall thickness is obtained for the part. Aperiod of time (e.g., 15 to 20 minutes) can be required betweensuccessive dipping processes to allow the previous coat of material toset sufficiently before initiating the next successive dip cycle. In thecase of a spherical reservoir, for example, 24 to 28 dip cycles may berequired to obtain a suitable wall thickness.

After a desired wall thickness is achieved, the reservoir produced bythe mandrel coating process may be subjected to additional processingsteps, such as placement in an oven for a curing process, for example.Curing is a step that is typically used in a process of preparing athermosetting (e.g., silicone) reservoir body of a penile implantdevice. In some cases, an oven curing process can take a significantamount of time, such as 6 to 8 hours. After the curing process iscomplete, the coated mandrel is removed from the oven and allowed tocool to room temperature. The cured reservoir is then manually removedfrom the mandrel to complete the process. The total time from start tofinish for a dip coating process can be 24 hours or more, and can bevery costly and labor intensive. In addition, the dip coating processcan require a relatively large manufacturing area, particularly whenmany reservoirs are being manufactured simultaneously.

The materials used for making reservoirs by dip-coating processes canalso be expensive and time consuming to prepare, which further increasesthe cost and timing of producing a dip-coated implantable reservoir. Oneexample of a material that is sometimes used in these dip-coatingprocesses is a silicone dispersion that is a two-part platinum curedispersion dispersed in xylene to convert from a semi-solid to aself-leveling liquid state. Preparation of the dispersion before it canbe used for a dip-coating process can take 24 hours or longer, includingthe time required for mixing and de-airing. For manufacturingefficiency, the batches of material are generally made in relativelylarge quantities, which are usually very expensive. The effective costof the dispersion further increases in cases where a portion of thedispersion is unused and must be discarded after its predeterminedusable life.

The production of dip-coated implantable reservoirs also can berelatively complicated due to the number of parts and bonds required toincorporate the reservoir into a device that can be used in a prosthesisdevice. As an example, four components are often used to produce atypical dip coated reservoir assembly. These components include a moldedsilicone shell adapter, a silicone stand pipe, a dip coated reservoirshell, and section of kink resistant tubing. In this reservoir assembly,each of the individual components is bonded to an adjacent componentusing a suitable adhesive, such as a medical grade silicone adhesive.Each time a bond is made, an air (ambient) cure is performed, whichgenerally take at least thirty minutes or longer, and which is followedby an oven cure generally for sixty minutes or longer before proceedingto the next bonding operation, thereby resulting in a process that isrelatively slow, and time consuming. Thus, it is desirable to producereservoir assemblies by methods and materials that are less costly thanthe production of reservoir assemblies using the dip coating and bondingmethods described above.

SUMMARY OF THE INVENTION

The invention relates to methods and devices that overcome certainshortcoming of prior fluid reservoirs for penile implant devices, and tomethods of manufacturing reservoir components (e.g., reservoir shells)and methods of incorporating the components (e.g., support structures)into an implantable prosthesis device. The invention provides fluidreservoirs for such devices that have improved manufacturability,improved fluid flow properties, or preferably both.

The invention can include the use of injection molding processes toproduce a fluid reservoir body for a penile implant device. Injectionmolding can eliminate multiple steps and the substantial time that canbe required to produce a reservoir by dip coating methods. Inparticular, injection molding methods can reduce the timing required toapply multiple coats of material during a dip coating method, andadditionally can be used to produce a reservoir assembly that includefewer pieces, thus requiring fewer bonding steps.

Another aspect of the invention can include a structure for animplantable reservoir that includes a support structure (e.g., in theform of multiple protrusions) at the base of the inside of the reservoirnear an exit orifice. The support structure can prevent the reservoirfrom collapsing during use such that a surface of the reservoir wouldcover the exit orifice. The support structure can preferably be includedin a reservoir body that is prepared by an injection molding method.

In one aspect, the invention relates to a fluid reservoir for a penileimplant device that includes a body portion having a sleeve from which atube may extend. The body portion includes support structure positionedat an interior surface of the body portion near an orifice of thereservoir, which orifice leads to a fluid passage of the tube. Inpreferred embodiments, the support structure may comprise a plurality ofprotrusions that are arranged around the orifice and that extend from abase portion of the body portion.

In another aspect, the invention relates to a method of manufacturing afluid reservoir for a penile implant device, including a step ofinjection molding a reservoir body. A preferred method can includepositioning a tube in a mold and injection molding a reservoir body ontothe tube. More particularly, the method may include providing a mold,positioning a tube in the mold, injecting material into the mold, curingthe material, and opening the mold to remove the reservoir body and tubeassembly.

The present invention also relates to methods and devices that overcomecertain shortcoming of prior fluid reservoirs for penile implant devicesby providing fluid reservoir structures for such devices that haveimproved fatigue resistance. The present invention also relates tomethods and devices that provide fluid reservoir structures that includeflow control structures.

In another aspect of the invention, a fluid reservoir for a penileimplant device includes a shell, an adapter, and preferably a tube. Theshell has an annular neck portion that defines an opening. The annularneck portion mates with an annular groove and a flange of the adapter toform a gradual transition from the adapter to the wall of the shell.Such a transition can help to control compliance mismatch between theadapter and shell and thereby provide improved reliability such as byproviding a more gradual change in wall thickness for improved fatigueresistance. The tube is preferably attached to the adapter to provide afluid passage that can be connected to another component of a penileimplant device.

In another aspect, the invention relates to a fluid reservoir for apenile implant device that includes a shell portion, an adapter portion,and preferably a tube. The shell includes a plurality of elements suchas ridges formed on an inside surface of the shell. The ridges arepositioned near a transition between the adapter and the shell. Suchridges can provide improved fatigue resistance by providing a smoothtransition between the adapter and the shell.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theappended Figures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIG. 1 is a top view of a three-piece implantable penile prosthesisdevice having a pair of penile prostheses, a pump, and a reservoir ofthe present invention;

FIG. 2 is a perspective view of one embodiment of a reservoir of thepresent invention;

FIG. 3 is a cross-sectional side view of the reservoir of FIG. 2,showing a shell attached to a support structure or device of an adapter,and a tube attached to the adapter at a sleeve;

FIG. 4 is a cross-sectional side view of the adapter portion of FIG. 3,also including an extending tube;

FIG. 5 is a perspective view of an adapter of the type shown in FIGS. 3and 4;

FIG. 5 a is a perspective view of another embodiment of an adapter ofthe present invention, including a support structure having elongatedelements alternating with shorter elements;

FIG. 5 b is a perspective view of another embodiment of an adapter ofthe present invention, including a support structure having multipleelongated elements;

FIG. 6 is a schematic top view of another embodiment of an adapterhaving one arrangement of c-shaped elements in accordance with thepresent invention;

FIG. 7 is a schematic top view of another embodiment of an adapterhaving another arrangement of c-shaped elements in accordance with thepresent invention;

FIG. 8 is a schematic cross-sectional front view of another embodimentof a portion of an adapter of the present invention, showing a contouredsupport structure;

FIG. 9 is a bottom view of one embodiment of a portion of a reservoirshell, showing a neck portion having a plurality of circumferentiallyspaced elements;

FIG. 10 is a perspective view of a portion of an embodiment of areservoir of the present invention, including a plurality of indentedregions circumferentially positioned around the neck region of thereservoir;

FIG. 11 is a cross-sectional view of another embodiment of a reservoirof the present invention, showing a body portion having a support devicewithin an interior space of a shell, a cap closing an opening in theshell, and a tube attached to the shell at a sleeve;

FIG. 12 is a perspective view of a cap of the type that can be used toclose or seal the opening in the shell of the reservoir of FIG. 11;

FIG. 13 is a cross-sectional view of the cap of FIG. 12;

FIG. 14 is a cross-sectional view of the reservoir of FIG. 11 takenalong the line 14-14; and

FIG. 15 is a partial cross-sectional front view of another embodiment ofa portion of an adapter of the present invention having an elongatedinner tubular structure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the Figures, wherein the components are labeled withlike numerals throughout the several Figures, and initially to FIG. 1,one preferred configuration of a surgically implantable penileprosthesis device 10 having a three-piece design is illustrated. Asshown, the device 10 generally includes first and second inflatablepenile cylinders 12 and 14, respectively, a pump 16, and a reservoir 18in accordance with the present invention. The first penile cylinder 12is fluidly coupled to the pump 16 by a tube 20 and the second penilecylinder 14 is fluidly coupled to the pump 16 by a tube 22. The pump 16is fluidly coupled to the reservoir 18 by a tube 24. Typically, thecylinders 12 and 14 are surgically implanted into the corpus cavernosaregions of a penis and the pump 16 is implanted within the scrotum of apatient, while the reservoir 18 is usually implanted within the abdomenof the patient. In use, the patient can activate the pump 16 in somemanner (e.g., squeezing the pump 16 in a particular way to open a valve)to move fluid from the reservoir 18 to inflate the penile cylinders 12and 14 and provide an erection. Similarly, the patient can activate thepump 16 to return fluid to the reservoir 18 and thereby deflate thepenile cylinders 12 and 14 and return the cylinders to a flaccidcondition. A wide variety of configurations of penile prosthesis devicesmay utilize a reservoir 18 of the type described herein, however, wherethe device 10 of FIG. 1 is intended to illustrate one representativesystem in which a reservoir 18 may be used. For example, a number ofdifferent types of pump configurations may be used, such as those thatrequire very little manipulation to move fluid between the reservoir andcylinders, or those that instead require the user to repeatedly squeezethe pump body for fluid transfer within the penile prosthesis device orsystem. In addition, devices having greater or fewer components than areused in a three-piece design can utilize the advantages of thereservoirs of the present invention.

FIGS. 2 and 3 show one embodiment of the reservoir 18 of the presentinvention, which generally includes a shell 26 having an interior space28 and an adapter 34 extending from the shell 26. Tube 24 is shown asextending from the adapter 34, although the tube 24 is not the only typeof device that can extend from the reservoir 18 for fluid communicationbetween the reservoir 18 and other adjacent devices or components. Forexample, additional or different adapters or devices may be connecteddirectly to one end of the adapter 34, in which case any tubing used mayoptionally be attached to the configuration at some other point distalfrom the shell 26 and adapter 34. In cases where such a tube 24 is used,however, the tube 24 preferably includes an inner fluid passage 36extending along its length through which fluid can move to and from theshell 26. Preferably, the tube 24 is a separate component that is sealedto the adapter 34 during a molding process as described below. However,the tube 24 may be molded as part of the adapter 34 or otherwise fusedor bonded to the sleeve 25 of the adapter 34 with an appropriatetechnique.

Further, the adapter 34 may include an annular flange 40 adjacent theshell 26, and a sleeve 25 spaced from the shell 26, where the tube 24may be attached to the adapter 34 at sleeve 25. The adapter 34preferably includes an opening 27 adjacent to the fluid passage 36 thatis configured to provide fluid communication between the tube 24 and theinner area of the annular flange 40. Thus, the opening 27 is preferablythe same shape and size as the fluid passage 36 to allow fluid to moveto and from the interior space 28 of shell 26 without fluid leakagebetween the components and to further allow fluid to move from theinterior space 28 of the shell 26, through fluid passage 36, and toother components to which the tube 24 is attached. For example,referring to the exemplary device 10 of FIG. 1, the reservoir 18 canprovide fluid to the pump 16 via tubing 24, and the pump cansubsequently transfer fluid to and from the penile cylinders 12 and 14.

Additionally referring to FIGS. 4 and 5, the adapter 34 is shown withoutan attached shell 26 to better illustrate the features of the adapter.As shown, the adapter 34 includes a body portion 38 and an annularflange 40. Preferably, the annular flange 40 increases in diameter fromthe area of the opening 27 in the adapter 34 toward the end of theflange 40. The body portion 38 also includes an annular groove 42 thatis at least partially defined by the flange 40 and body portion 38, asillustrated. That is, the body portion 38 generally provides an interiorsurface of the groove 42 and an interior surface 46 of the flange 40provides an exterior surface of the groove 42, where the exteriorsurface of the groove is spaced from the body portion 38 by a distancethat corresponds with the desired width of the annular groove 42. Thewidth of the groove 42 is preferably designed to accept the free edge ofa shell of a reservoir assembly. Referring again to FIG. 3, the shell 26preferably includes an annular neck portion 44 that fits into theannular groove 42. When the shell 26 is positioned so that its neckportion 44 is positioned within the groove 42, the interior surface 46of the flange 40 will preferably be in contact with the outer surface ofthe shell 26. Thus, the flange 40 is preferably flexible enough that itcan conform generally to the outside shape of the shell 26 in both itsexpanded and collapsed conditions. Further, when the neck portion 44 ispositioned within the groove 42, the inside surface 46 of the flange 40may be adhered or otherwise bonded to the outside surface of the shell26 at the neck portion 44. In addition or alternatively, an outsidesurface of the body portion 38 may be bonded to an inside surface of theannular neck portion 44 in order to secure the shell 26 to the adapter34. In addition, the inside surface 46 of the flange 40 may also beadhered to the portion of the shell 26 beyond the neck portion 44, suchas where the diameter of the shell 26 increases and beyond the areawhere the neck portion 44 is positioned within the annular flange 40. Itis contemplated that the thickness of the neck portion may vary and/orthat the width of the annular gap may change along its length. For anyportions of the reservoir components that are bonded to each other, anymedical grade adhesive or the like may be used.

Referring again to FIGS. 3 and 4, the flange 40 is tapered in thicknessas the flange 40 extends outwardly away from the body portion 38 so thatthe flange 40 is thickest in the area closest to the body portion 38,then tapers down to a smaller thickness when moving away from bodyportion 38. Preferably, the flange 40 tapers down to a point or smallradius at its furthest position from the body portion 38 (i.e., the endof the flange 40). By using such a tapered flange 40, as shown, a smoothtransition can be provided at the transition of the body portion 38 ofthe adapter 34 to the shell 26. Alternatively, the annular flange 40 mayflare or splay further outward than is shown in FIG. 3. In this case,the neck of the shell should preferably be designed accordingly to matewith the annular flange and annular gap of the adapter without placingadded stresses on the material of the flange and/or reservoir shell.

When a penile prosthesis device utilizing a reservoir 18 of theinvention is implanted in a user, the shell 26 may be repeatedlydeflated and inflated. During deflation, the shell 26 collapses inwardlyon itself and flexes at the neck portion 44 (as well as at other partsof the shell 26). Such repeated flexing can cause fatigue at the neckportion 44, which could cause a gradual thinning of the wall andeventual failure (e.g., leakage) between the shell 26 and flange 40.Thus, the flange 40 is desirably configured to provide additionalsupport at the neck portion 44 while also providing a smooth transitionfrom the body portion 38 of the adapter 34 to the shell 26 andminimizing areas of stress concentration. In other words, at a pointnear the body portion 38 of the adapter 34, the neck portion 44 ispreferably sealed or attached to the flange 40. The total wall thicknessin this region near the body portion 38 thus includes the thickness ofthe flange 40 plus the thickness of the wall of the neck portion 44.However, the combined thickness of the flange 40 and the wall of theneck portion 44 will decrease at points that are spaced further from thebody portion 38 due to the decrease in the flange thickness. Thus, asthe flange 40 tapers down to its end or edge, the combined thicknessgradually reduces or transitions to the thickness of the wall of theshell 26. This reduces compliance mismatch between the adapter 34 andthe shell 26 and can provide improved reliability of the reservoir 18.Generally, compliance mismatch refers to a change in flexibility orcompliance at a transition such as an abrupt transition from a thicksection to a thin section. At such an abrupt transition, regions ofconcentrated stress may occur which could lead to premature fatigue andperhaps failure. The present invention thus provides a smooth andgradual transition between a portion of an adapter or base portion to athinner portion of a shell or a reservoir.

Again referring to FIGS. 4 and 5, the adapter 34 preferably includes asupport structure 47 that comprises a plurality of elements 48. Theelements 48 are positioned within an interior space 50 of the bodyportion 38. In one preferred embodiment, the elements 48 are arrangedcircumferentially around the opening 27 to the fluid passage 36. Theelements 48 preferably have a generally cylindrical shape as they extendaway from the opening 27; however, the elements 48 may be any of a widenumber of regular or irregular shaped structures. Each of the pluralityof elements 48 within a particular adapter 34 may be shaped and sized tobe identical to one another, or may instead have a different size,shape, and/or height from other adjacent elements 48.

The shells of the reservoirs of the present invention are generallyshown as having a spherical, oval, or elliptical shape. However, theshell may instead have a more irregular or asymmetrical shape, or mayinclude a shell that has another configuration, such as a shell that ismore cylindrical in shape, kidney-shaped, disk-shaped, or shaped in someother way (with an appropriate size and material) so that the shell canexpand or “inflate” to receive a desired amount of fluid. The shellshape should also contract or “deflate” with the removal of fluid fromthe reservoir. With any of the shapes chosen for the shell, anassociated adapter should be designed to accommodate attachment of aportion of the shell to the adapter or molding of the shell adapter intoone integral structure. For example, the flange portion may need to bemore or less tapered to provide a smooth transition between the shelland adapter. The adapter may or may not include an annular gap in whicha portion of the shell is positioned and attached, and other features ofthe shell and adapter may be designed to provide a shell and adapterthat can expand and collapse in accordance with the present invention.

Because the devices in which reservoirs of the present invention areused will preferably be closed fluid systems, as fluid is transferredfrom a reservoir, the shell will collapse on itself as the penilecylinders inflate. The manner in which a shell, such as the shell 26,collapses or folds is generally unpredictable, so any part of the shell26 could collapse toward the opening or orifice 27 and thereby restrictor block fluid flow through the passage 36 without the use of anotherconfiguration or structure. In use, the elements 48 can thus function toprevent the opening 27 from being blocked by some part of the shell 26when it collapses due to fluid being moved from the reservoir 18 towardpenile cylinders by a pump, for example. The elements 48 can preventsuch flow problems and blockage because as the shell 26 collapses, oneor more of the elements 48 will keep the shell 26 spaced from theopening 27, thereby preventing fluid flow blockages. Thus, it ispreferable that the elements 48 are provided with at least a small spacebetween them to allow sufficient fluid flow. As such, fluid can flowbetween the spaced apart elements 48, even if a portion of the shell isresting on the elements 48. Further, the elements may be completelydiscrete components that individually extend from a base area, or mayinstead be molded or formed with at least some attachment betweenadjacent elements along the height of the elements. Variations of a flowcontrol device or support device or structure other than thatspecifically shown in the figures of the present application may beused.

FIG. 5 a illustrates another embodiment of an adapter 34 a for use witha shell that can be attached thereto to make a reservoir assembly, wherethe adapter 34 a includes a body portion 38 a, an annular flange 40 a,and a support structure 47 a extending generally from the body portion38 a. The support structure 47 a includes a plurality of elements 48 apositioned within an interior space of the body portion 38 a. In onepreferred embodiment, the elements 48 a are arranged circumferentiallyaround the opening to a tube 24 a that extends from the body portion 38a. As shown, this embodiment includes eight total elements 48 a, withfour of the elements 48 a having the same height as each other, which isa greater height than that of the other four elements 48 a, which alsohave the same height as each other. In this embodiment, the fourelements 48 a having the greater height actually extend beyond the endof the annular flange 40 a, while the other four elements 48 a do notextend beyond the end of the flange 40 a. As shown, the elements 48 ahaving the greater height are a different shape than those having thelesser height; however, any number of combinations of shapes and heightsare considered to be within the scope of the present invention. Forexample, in the embodiment of FIG. 5 a, all of the elements 48 a mayhave identical cross-sections, or each of the elements 48 a may have adifferent cross-section than each of the other elements 48 a. Also, agiven adapter may have elements with more than two heights, if desired.Additionally, as described herein relative to other embodiments of theinvention, the selection of the number, configuration, height, and otherfeatures of the adapter elements is preferably selected to prevent orminimize blocking of fluid flow to and from an attached shell, andparticularly to keep an attached shell from collapsing and blocking thefluid opening.

FIG. 5 b illustrates another embodiment of an adapter 34 b of thepresent invention. The adapter 34 b again includes multiple elements 48b extending from a body portion 38 b, where all of the elements 48 bextend beyond the end of a flange 40 b. In this case, alternatingelements 48 b have different cross-sections around the circumference ofthe body portion 38 b such that half of the elements 48 b have acircular cross-section and the other half of the elements 48 b have anoval or elliptical cross-section. However, it is possible that all ofthe elements 48 b have the same cross-sectional shape or that the groupof elements 48 b includes more than two different element shapes.

In FIG. 6, a schematic top view of another embodiment of an adapter 60of the present invention is shown. The adapter 60 includes a pluralityof c-shaped elements 62 that can be used as an alternative to theelements 48 shown in FIGS. 4 and 5. Elements 62 are arranged with theopen portion of each c-shape facing another adjacent element 62 toadvantageously provide channels for fluid to flow both between theelements and also within the c-shaped portion of the elementsthemselves. In FIG. 7, another embodiment of an adapter 64 is shown. Theadapter 64 includes a plurality of c-shaped elements 66 that arearranged so that the c-shapes all face the center of the adapter 64.Again, these elements 66 are preferably arranged to provide channels forfluid flow between and within the individual elements 66.

Also, in FIG. 8, a schematic cross-sectional view of another embodimentof an adapter 68 of the present invention is shown. The adapter 68includes a support structure 70 having a textured or contoured surface72 surrounding a fluid passage 74. The surface 72 may simply includesuch a contoured surface as shown, or alternatively may include someother type of contours or structures such as scallops, ridges, buttons,protrusions, bumps, channels, and/or other support structures that havethe capability to hold or support at least a portion of a wall of ashell away from an opening to the fluid passage 74. In this way, thesurface 72 allows fluid to flow through the passage 74 even if a portionof the shell collapses near the orifice of the fluid passage 74 insidean attached reservoir.

The adapter 68 further includes an annular flange 80 and an annularridge portion 82, both of which are spaced from and circumferentiallysurround the fluid passage 74. Specifically, the ridge portion 82 isspaced from both the fluid passage 74 and the contoured surface 72 andpreferably extends at least slightly beyond the surface 72 to furtherprevent an attached reservoir shell from collapsing onto and blockingthe fluid passage 74 when the shell is at least partially deflated. Theridge portion 82 is also preferably spaced from the annular flange 80 toprovide an annular groove 84 in which a portion of a shell may bereceived, such as described above relative to FIGS. 3 through 5. Such ashell position may also involve bonding or other types of attachments tosecure a shell to the adapter 68.

Another embodiment of an adapter 168 is illustrated in FIG. 15 andincludes a primary fluid passage 174 that extends generally through thecenter of the adapter 168. The adapter 168 further includes an annularflange 180 that is spaced from and circumferentially surrounds thatpassage 174, and an annular tube extension 190 that closely surroundsthe passage 174. An additional annular ridge portion 182 may alsooptionally be included in the structure and positioned between the tubeextension 190 and the flange 180. The tube extension 190 is preferablyhigh enough to extend past the end of the annular flange 180, as shown,so that if an attached shell collapses, it will contact the tubeextension 190. To promote fluid flow, the tube extension 190 alsopreferably includes a series of perforations or openings 196 throughwhich fluid can flow for fluid movement between the fluid passage 174and an attached shell. The perforations or openings 196 are preferablyin direct fluid communication with the primary fluid passage 174 and thearea immediately surrounding the extension 190, as shown. Theperforations 196 may be sized and spaced around the circumference oftube extension 190 in any desired configuration that provides thedesired fluid flow without compromising the strength of the tubeextension (i.e., the extension 190 should not collapse or otherwisedeform significantly).

The tube extension 190 may have either an open end that allows fluid toflow directly to and from the fluid passage 174 when a collapsed shellis not resting on the end of extension 190, or the tube extension 190may instead have a closed end so that the only fluid communication withthe fluid passage 174 is via the perforations 196. Further, whenperforations or openings are used along the length of the extension 190,the perforations may have any of a wide variety of shapes and sizes,such as the circular shaped perforations 196 of FIG. 15. The number ofperforations for a particular tube extension 190 may also vary, and theshape, locations, and spacing of the perforations may be different,depending on the configuration of the adapter. The tube extension 190may optionally include a shaped feature at its end (e.g., a sphere, anellipse, or the like) that will extend into the inner area of anattached reservoir shell. The shaped feature can help to maintainpatency and minimize wear or damage to a collapsed shell that issupported on its surface. Whether or not such a feature is used, it ispreferable that the surfaces of the tube extension 190 are relativelysmooth and free from sharp edges that might damage a shell surface.

The tube extensions of the invention can be manufactured and assembledusing a wide variety of methods. One example is to mold the tubeextension as part of its associated adapter, so that the tube extensionand adapter comprise one molded component. The tube extension may alsobe molded or extruded as a separate component that is bonded in some wayto the adapter. The tube extension could also be over-molded onto theattached tubing, such that this dual-tube component could be bonded orattached to the adapter using any appropriate attachment or bondingmethod. When perforations are included in the tube extension, they canbe made during the molding process or in a secondary operation after thetubing is manufactured.

While the embodiment of FIG. 15 particularly describes the use ofperforations with a tube extension of an adapter, other embodiments ofthe present invention can likewise utilize perforations to provideadditional fluid flow between the shell and a fluid passageway. Forexample, the elements 48 of FIG. 5 may include at least one perforationor opening and an associated fluid passageway that is in fluidcommunication with the fluid passageway 36 to provide an additional pathfor the fluid to move between the shell and fluid passageway.

In another aspect of the present invention, which is illustrated in FIG.9, a shell 90 of a reservoir may include multiple structures or elements92, such as ribs or protrusions, for controlling compliance mismatchbetween an adapter and the shell 90 for a multi-component reservoir.Such structures or elements 92 may also be used to control compliancemismatch for a reservoir where the adapter and shell are molded orformed as a single piece. Preferably, a plurality of elements 92 arespaced from each other around the circumference of the shell 90 in thearea generally adjacent the neck portion 94 of the shell 90. However,the elements 92 may instead be positioned at the opening of the neckportion 94 (i.e., the edge or end of the shell 90) or further into theinterior surface of the shell 90 such that they would not be visiblewhen viewing the shell 90 from the edge of the neck. Such elements 92can provide a smooth transition from an adapter or the like to theshell. That is, a gradually tapered wall thickness from an adapter orthe like to a shell can be provided.

The elements 92 preferably protrude from the inner wall of the shell 90toward an interior space 96 of the shell 90 and have at least a smallspace between adjacent elements to promote fluid flow, even when theshell is collapsed. The elements 92 may have any of a wide variety ofconfigurations that provide the desired control of compliance mismatchbetween the shell and an adapter, such as cylinders or ribs that havethe same or different dimensions along their lengths. In other words,the elements 92 may also have a tapered width or thickness along theirlengths. The elements 92 may be any structure or surface that helps totransition at least a portion of an adapter or the like to a shell 90 byproviding a smooth transition between the two, and preferably are shapedto provide a gradual transition from an adapter or the like. Forexample, the elements 92 may be formed as bumps or ridges or otheroutwardly extending features or the like. Preferably, the elements 92are formed as spherical or elliptical or generally smooth curvingstructures in order to allow free flow of fluid while minimizingfrictional resistance.

When a plurality of elements 92 are spaced circumferentially from eachother, as described above, the elements 92 may be spaced apart at anydesired distance, which will often be designed along with the number ofelements used to achieve particular flow characteristics. For example,in one preferred arrangement, the spacing of the elements may be equalto or less than a width of each element. Additionally, the elements 92preferably extend lengthwise along the neck portion 94 of a shell 90 andmay extend beyond the neck portion 92 into a body portion of a shell 90.

FIG. 10 illustrates another embodiment of a reservoir that includesfeatures that can help to control (such as by reducing) compliancemismatch. The reservoir 86 of this figure includes multiple indentedregions 87 spaced from one another that may form protrusions on aninside surface of the neck portion of the reservoir. The indentedregions 87 are positioned near a transition between the neck and thebody of the shell. As shown in FIG. 10, the indented regions 87 have agenerally square shape; however, the regions 87 may instead have a widevariety of shapes and dimensions, such as a generally rectangular shape,a curved shape, or any other shape that provides the desired control ofcompliance mismatch between materials and/or material thicknesses thatyield differently under applied loads. These features are preferablyselected to promote patency through the fluid flow passage. The indentedregions 87 may also be longer than shown so that they extend furtheronto the shell and/or neck regions of the reservoir, or may be shorterso that they do not extend as far onto the shell and/or neck regions ofthe reservoir. The indented regions 87 may be more or less recessed intothe neck portion of the reservoir, depending on the desired propertiesof this region. Further, the use of these indented regions may be usedalone or in combination with any of the other design features of thepresent invention described herein.

In another aspect of the invention, a lubricity enhancing coating suchas a parylene coating or the like may be applied to at least a portionof an inside surface of a reservoir, such as is described relative topenile prosthesis components, for example, in U.S. Pat. No. 6,558,315(Kuyava) and U.S. Patent Application Publication No. 2003/0220540(Kuyava), both of which are commonly owned by the assignee of thepresent invention. Another example of the use of parylene coatings forartificial sphincters is further described, for example, in U.S. PatentApplication Publication No. 2003/0028076 (Kuyava et al.), which is alsocommonly owned by the assignee of the present invention. A parylenecoating may be applied by using conventionally known techniques such asvapor deposition or the like, for example. Such a lubricity enhancingcoating can improve the frictional characteristics of an inside surfaceof a reservoir and the durability of the reservoir. This can improvereliability of a reservoir by controlling frictional effects on aninside surface of a reservoir that can result during inflation anddeflation of such reservoirs.

In another aspect of the invention, at least some of the components ofthe penile implant devices can be coated on their outer surfaces with anantimicrobial agent, including the cylinders, pump and/or reservoir.Examples of coating antimicrobial agents on implantable medical devicesare described, for example, in U.S. Pat. No. 6,534,112 (Bouchier et al.)and U.S. Patent Application Publication No. 2004/0040500 (Bouchier etal.), both of which are commonly owned by the assignee of the presentinvention.

FIG. 11 illustrates another embodiment of a reservoir 118 in accordancewith the present invention, which can be used in the same types ofimplantable devices as described above, such as a three-piece penileprosthesis device of the type shown in FIG. 1, for example. As shown,the reservoir 118 includes a body portion or shell 126 having aninterior space 128, an opening 132 at one end of the shell 126, and acap 130 that is positioned to close or seal the opening 132 in the shell126. The reservoir 118 further includes a sleeve portion or adapter 134extending from the shell 126. Tube 124 extends from the sleeve portion134 in this embodiment; however, it is possible that the sleeve portion134 instead is fluidly connected to some other components or deviceswithout the use of tubing, such as tube 124. In cases where such a tube124 is used, the tube 124 preferably includes an inner fluid passage 136extending along its length through which fluid can move to and from theinterior space 128 of the shell 126. The reservoir 118 further includesa support structure 138 within the interior space 128 of the shell 126.

As shown in FIG. 11, the sleeve portion 134 is coupled with the tube 124to define the fluid passage 136 for moving fluid to and from theinterior space 128 of the body portion 126. Fluid can move from theinterior space 128, through fluid passage 136, and to other componentsto which the tube 124 is attached. For example, referring to theexemplary device 10 of FIG. 1, the reservoir can supply fluid to thepump 16 via tubing 24, which can subsequently transfer fluid to and fromthe penile cylinders 12 and 14. Preferably, the tube 124 of FIG. 11 is aseparate component that is sealed to the sleeve portion 134 during themolding process as described below. However, the tube 124 may be moldedas part of the shell 126 or otherwise fused or bonded to the sleeveportion 134 with an appropriate technique.

A perspective view of one embodiment of the cap 130 is shown in FIG. 12and a cross-sectional view of that cap 130 is shown in FIG. 13. Asdescribed below, the opening 132 of the shell 126 is created due to theprocesses used for molding the reservoir 118 of this embodiment, whichincludes using this opening 132 to remove a mold after the reservoir 118is formed. In order to seal this opening 132 and make the shell 126 intoa closed volume, the cap 130 can be used to completely cover the opening132, such as with a suitable adhesive or the like, to provide afluid-tight seal. For example, medical grade silicone adhesive or thelike may be used. As shown, the cap 130 preferably includes a curvedouter surface 150 that generally matches the curve of the shell 126 sothat the surface 150 essentially makes the shell 126 into a continuous,smooth structure. In addition, the cap 130 also preferably has aninsertable portion 152 that has a smaller diameter than that of thecurved surface 150, where the diameter of the insertable portion 152 isgenerally the same as the diameter of the opening 132 in the shell 126.

In preferred embodiments of the invention, the reservoir 118 (andspecifically the interior space 128 of the shell 126) includes a supportstructure positioned near an exit area or orifice 127 of the shell 126.In particular, the support structure 138 is preferably positioned to begenerally opposite the opening 132 and cap 130 of the shell 126. Duringuse, liquid inside the reservoir 118 can transfer fluid from itsinterior space 128 to fill the inflatable cylinders of the prosthesis.As fluid exits the shell 126, the reservoir 118 empties with anattendant collapse of the flexible walls of the shell around the volumeof the displaced liquid. This collapse is due to the flexible materialfrom which the shell 126 is preferably designed and the variouspressures that are placed on the outside of the shell 126 from theuser's bodily organs, fluids and the like, along with fluid pressureswithin the system that tend to create a negative pressure within thereservoir 118 as fluid is transferred from the interior space 128. It ispreferred that when the shell 126 of the reservoir 118 collapses onitself, that the internal surface of the shell 126 does not partially orcompletely cover the exit orifice 127 and interfere with flow of thefluid through the exit orifice 127. A support structure according to theinvention is thus used to prevent such blockage of the orifice 127 andis preferably a structure that, during use, prevents the internalsurfaces of the shell 126 from covering the exit orifice 127. Theparticular form and shape of the support structure can include a widevariety of configurations, such as a number of elements or protrusionsof the same or different shapes and sizes arranged around the exitorifice 137. The elements may be relatively round or oval or otherwiseshaped in cross section, of the same or different sizes, or of irregularshapes.

Referring to FIGS. 11 and 14, one particular embodiment of the supportstructure 138 includes a plurality of elements 140 that extend from abase portion 142 of the shell 126 of the reservoir 118. The elements 140are positioned within the interior space 128 of the shell 126. Referringto FIG. 14 in particular, multiple elements 140 are arrangedcircumferentially around orifice 127, preferably with at least a smallspace or gap between adjacent elements 140. In this embodiment, thesupport structure 138 specifically includes four cylindrically shapedprotrusions 146 that have a generally circular cross-section as theyextend away from the base portion 142. The support structure 138 of thisembodiment also includes four elements 148 that have a cross-sectionalshape different from that of elements 146. As shown, the elements 148have a width similar to the diameter of elements 146 and a length thatis greater than the radius of elements 146. Elements 146 and 148 arearranged to alternate with each other around orifice 127 such that thereis a gap between each adjacent elements 146 and 148. The differentcross-sectional shapes of the alternating adjacent elements arepreferably selected and designed to prevent or minimize the elements 146and 148 from themselves becoming squeezed together or otherwisecollapsing into themselves and blocking or inhibiting flow of fluidthrough orifice 127.

In use, a support structure, such as the illustrated support structure138, can function to prevent orifice 127 from becoming blocked or closedby some part of the shell 126 as fluid moves from reservoir 118 topenile prostheses and the shell 126 collapses on itself. Without asupport structure of the type described herein, the manner in which ashell (such as shell 126) collapses or folds is generally unpredictableso any part of the shell 126 could collapse onto orifice 127 and therebyrestrict or block fluid flow through the passage 136. A supportstructure according to the invention can prevent such flow problemsbecause as the shell 126 collapses, the shell 126 can be supported orheld at a distance away from the orifice 127 by the support structure(e.g., protrusions 146 and 148). Fluid can then flow through the orifice137 between the elements 146 and 148.

As shown in the exemplary reservoir 118 of FIGS. 11 and 14, the shell126, sleeve 134, and support structure 138 are preferably formed as anintegral structure (i.e., a single piece construction); however, it ispossible that the components are arranged as separate components thatare connected or attached to each other. In any case, the tube 124 ofthis embodiment is preferably formed as a separate structure that isattached to sleeve 134 as described below. As described above, cap 130is also formed as a separate structure that is attached to shell 126when desired.

When the shell 126, sleeve 134, and support structure 138 are made of asingle piece, the configuration may be formed by injection molding.Methods of injection molding may include the use of a flowable material(e.g., thermoplastic or thermosetting), such as a polymeric material,and a mold. The flowable material is placed at a desired temperature(e.g., by heating) and is injected into a cavity to produce a moldedcomponent (here, a fluid reservoir). The mold is then opened, optionallyafter cooling, and the molded component can be removed from the mold andoptionally cured. In particularly preferred embodiments, a reservoir canbe prepared by injection molding methods, wherein the reservoir includesa shell, a sleeve, and support structure. The reservoir may be molded tobecome attached to a tube at the exit orifice of the reservoir shell.That is, by preferred injection molding processes, an elongated tube,such as tube 124, can be attached to the reservoir during a process ofinjection molding the reservoir. To do this, the tube can be positionedonto a mandrel of a mold. A relatively spherical, solid mold core pin isalso included, which is a form for the inside of the reservoir. Outersections of the mold that define the outer surfaces of the reservoir arethen placed around the core pin to thereby create a cavity that is thesize and shape of the fluid reservoir (including the sleeve and supportdevice). The entire mold is then brought to a processing temperature,then a predetermined amount of a desired material is injected into themold over the tube and the spherical mold core pin to fill the cavity.After a predetermined time, the mold is opened and the reservoir withthe attached tube is removed from the mold, with the sleeve therebybecoming molded around the outside diameter of the tube as the sleevebody portions of the reservoir are formed.

The reservoir, being of a flexible material, can be removed from aroundthe core pin following cooling or curing of the flexible material asnecessary. Removal of the reservoir from the core pin can be done bystretching the reservoir material around the core pin. Optionally,water, soap, air, or a combination of these, can be used to separate theinside surface of the reservoir from the core pin. One especiallyconvenient and effective way to introduce any of water, soap, and air,to the space between the core pin and the inside of the reservoir, is toinject any one or more of these through the tube connected to thereservoir.

As one example, a reservoir may be made from liquid silicone rubber. Amold temperature in the range of 250° F. (121° C.) to 275° F. (135° C.)may be used. Also, a molding time of approximately 2.5 minutes may beused. Alternatively, the reservoir may be made from any other useful,flexible medical or industrial material that is biologically inert andnon-reactive with the inflating fluid that will be contained by thereservoir. The material may be thermosetting or thermoplastic. Specificexamples of useful materials can include thermosetting silicone rubber(e.g., polydimethyl siloxane), thermosetting or thermoplastic urethanes,C-flex, santoprene thermoplastics, and the like.

The present invention has now been described with reference to severalembodiments thereof. The entire disclosure of any patent or patentapplication identified herein is hereby incorporated by reference. Theforegoing detailed description and examples have been given for clarityof understanding only. No unnecessary limitations are to be understoodtherefrom. It will be apparent to those skilled in the art that manychanges can be made in the embodiments described without departing fromthe scope of the invention. Thus, the scope of the present inventionshould not be limited to the structures described herein, but only bythe structures described by the language of the claims and theequivalents of those structures.

1. A fluid reservoir for use in a penile prosthesis device, thereservoir comprising: a shell comprising an inner fluid storage area anda neck opening; an adapter extending from the neck opening of the shelland comprising a base portion, an orifice, and an annular flangeextending from the base portion and spaced radially from the orifice;and a support structure extending from the base portion of the adapterinto the inner fluid storage area, wherein the support structure isadapted to prevent the shell from blocking fluid flow through theorifice.
 2. The fluid reservoir of claim 1, wherein the adapter and theshell comprise a single, integrally molded piece.
 3. The fluid reservoirof claim 2, wherein the integrally molded adapter and shell piececomprises an injection molded construction.
 4. The fluid reservoir ofclaim 1, wherein the adapter is bonded to the shell.
 5. A fluidreservoir for use in a penile prosthesis device, the reservoircomprising: a shell comprising an inner fluid storage area and a neckopening, wherein the shell comprises a flexible wall portion extendingfrom the neck opening and comprising a mold opening spaced from the neckopening, and a cap positioned to cover the mold opening; an adapterextending from the neck opening of the shell and comprising a baseportion and an orifice; and a support structure extending from the baseportion of the adapter into the inner fluid storage area, wherein thesupport structure is adapted to prevent the shell from blocking fluidflow through the orifice.
 6. The fluid reservoir of claim 5, wherein thecap is bonded to the mold opening.
 7. The fluid reservoir of claim 1,wherein the shell comprises an injected molded piece.
 8. A fluidreservoir for use in a penile prosthesis device, the reservoircomprising: a shell comprising an inner fluid storage area and a neckopening; an adapter extending from the neck opening of the shell andcomprising a base portion and an orifice; and a support structureextending from the base portion of the adapter into the inner fluidstorage area, wherein the support structure is adapted to prevent theshell from blocking fluid flow through the orifice, and wherein thesupport structure comprises a plurality of elements extending from thebase portion into the inner fluid storage area.
 9. The fluid reservoirof claim 8, wherein each of the plurality of elements has an identicalstructure to each of the other elements extending from the base portion.10. The fluid reservoir of claim 8, wherein at least one of theplurality of elements comprises a different structure than at least oneof the other elements extending from the base portion.
 11. The fluidreservoir of claim 10, wherein at least one of the plurality of elementsis different in at least one of a height and a cross-sectional shapethan at least one of the other elements extending from the base portion.12. The fluid reservoir of claim 8, where at least one of the elementscomprises an inner fluid channel and at least one perforation for fluidcommunication between the inner fluid storage area and the inner fluidchannel of the element.
 13. The fluid reservoir of claim 1, wherein theadapter further comprises an annular gap between the annular flange andthe support structure for receiving at least a portion of the shell. 14.The fluid reservoir of claim 13, wherein the shell is bonded within theannular gap of the adapter.
 15. The fluid reservoir of claim 1, whereinthe support structure further comprises a plurality of elementsextending from the base portion into the inner fluid storage area andwherein at least one of the plurality of elements extends a greaterdistance from the base portion than the annular flange.
 16. A fluidreservoir for use in a penile prosthesis device, the reservoircomprising: a shell comprising an inner fluid storage area and a neckopening; an adapter extending from the neck opening of the shell andcomprising a base portion and an orifice; and a support structureextending from the base portion of the adapter into the inner fluidstorage area, wherein the support structure is adapted to prevent theshell from blocking fluid flow through the orifice, wherein the supportstructure comprises a tubular extension extending from the base portionand having an inner primary fluid passage to the orifice, and whereinthe tubular extension comprises at least one perforation for fluidcommunication between the inner fluid storage area and the primary fluidpassage.
 17. The fluid reservoir of claim 16, wherein the tubularextension comprises a closed end distal from the base portion.
 18. Thefluid reservoir of claim 16, wherein the tubular extension comprises anopen end distal from the base portion, wherein the open end is in fluidcommunication with the primary fluid passage and the inner fluid storagearea.
 19. The fluid reservoir of claim 1, wherein the shell isexpandable to an expanded state and collapsible to a collapsed state inresponse to fluid movement into and out of the inner fluid storage area,respectively.
 20. The fluid reservoir of claim 8, wherein each of theplurality of elements is spaced circumferentially from each of the otherelements around the orifice of the adapter.
 21. A fluid reservoir foruse in a penile prosthesis device, the reservoir comprising: a shellcomprising an inner fluid storage area and a neck opening; an adapterextending from the neck opening of the shell and comprising a baseportion, a tube extending from the base portion, and an orifice throughthe base portion for fluid communication between the inner fluid storagearea and the tube; a support structure extending from the base portionof the adapter into the inner fluid storage area in the oppositedirection of the tube extension from the base portion, wherein thesupport structure comprises at least one extending element.
 22. Thefluid reservoir of claim 21, wherein the shell, the adapter, and thetube comprise a single, integrally molded piece.
 23. A fluid reservoirfor use in a penile prosthesis device, the reservoir comprising: a shellcomprising an inner fluid storage area and a neck opening; an adapterextending from the neck opening of the shell and comprising a baseportion, a tube extending from the base portion, and an orifice throughthe base portion for fluid communication between the inner fluid storagearea and the tube; a support structure extending from the base portionof the adapter into the inner fluid storage area in the oppositedirection of the tube extension from the base portion, wherein thesupport structure comprises at least one extending element, wherein theat least one extending element comprises a plurality of elementscircumferentially positioned around the orifice of the adapter.